Hand InjuriesNCT01210833
Using HandTutor With Traumatic Hand Injuries: Characterizing the System
A study testing HandTutor System in people with Hand Injuries, run by Meir Medical Center at 1 site in Israel.
Trial summary
HandTutor is a computerized system designed to evaluate and rehabilitate hand function. It is composed of a glove with optic sensors detecting the movements of the wrist and the fingers with a biofeedback software designed to evaluate and then to exercise the hand movements through supplying a variety of computer… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Hand Injuries
- What is being tested?
- HandTutor System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2010to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Hand Injuries causing a disfunction of one finger or more of the fingers 2nd-5th.
- Six weeks at least after the injury/surgery.
- Allowed to exercise their fingers with no contraindications according to the orthopedic surgeon instructions.
- With no open wounds.
Who cannot join
- Peripheral nerves injuries.
- Digital nerves injuries.
- Sensation problems.
- CRPS-complex regional pain syndrome.
- Cognitive impairments.
- Head trauma.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Clalit Health Service, Southern Clinic, Occupational Therapy Department
Naẕerat ‘Illit
About this study
HandTutor is a computerized system designed to evaluate and rehabilitate hand function. It is composed of a glove with optic sensors detecting the movements of the wrist and the fingers with a biofeedback software designed to evaluate and then to exercise the hand movements through supplying a variety of computer graphic patterns.
The HandTutor has been used and tested with a stroke population, and it seems potential to be used with hand injuried population. As a first step, it is important to investigate the characteristics of the system and how it is matching the hand injuried population.
Read more
The purpose if this study is to characterize the HandTuror system and the focused objectives are:
- To examine the test-retest reliability of the system when measuring the range of motion (ROM) of the the fingers among healthy people (control group).
- To examine the correlation between the ROM measured by the HandTutor and the ROM measured by conventional assessment tools (goniometer).
- To examine the ability of the system to distinguish between healthy people and hand injured people.
- To examine the correlation between the performance in the HandTutor (in the games part), and the performance in functional activities.
- To examine the participants feedback for using the HandTutor (degree of enjoyment).
- Conditions
- Hand Injuries
- Being tested
- HandTutor System
- Keywords
- Finger Fractures, Tendon Injuries, Soft Tissue Injuries
- Medical subject headings
- Hand Injuries, Tendon Injuries, Soft Tissue Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HandTutor SystemDevice
Computerized system designed to evaluate and rehabilitate hand function. It is composed of a glove with special sensors detecting the movements of the wrist and the fingers, with a biofeedback software designed to evaluate and then to exercise the hand movements through supplying a variety of computer graphic patterns.
| Study group | Role | What they receive |
|---|---|---|
| Healthy participants | Active comparator | Healthy participants aged from 18 to 60 with no history of hand injuries recruited by convenience sampling. Receives: Device: HandTutor System |
| Hand Injured participants | Experimental | Participants with hand injuries aged from 18 to 60 recruited from the outpatients attending the occupational therapy clinic. Receives: Device: HandTutor System |
What is being measured
The primary outcome is the main question the study is designed to answer.
range of movement (ROM)
Passive and active ROM measured by goniometer, passive and active ROM measured by HandTutor
Measured: up to 12 months after the injury
Secondary outcomes (5)
performance in HandTutor
The final score the participants get when exercising with the HandTutor.
Measured: up to 12 months after the injury
daily life functioning
Measured by DASH-Disability of Arm,Shoulder and Hand Questionnaire, and by Jebsen-Taylor Hand Function Test.
Measured: up to 12 months after the injury
motor performance skills
Measured by Purdue Pegboard Test
Measured: up to 12 months after the injury
enjoyment
Measured by SFQ-Specific feedback questionnaire.
Measured: up to 12 months after the injury
pain
Measured by VAS-Visual analogue scale.
Measured: up to 12 months after the injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2010 (estimated)
- Study startOct 2010
- Primary completionFeb 2012
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Manal A. Najjar, M.Sc. in O.T, Study director, Clalit Health Service, Southern Clinic, Occupational Therapy Department, Naẕerat 'Illit, Israel, 04-6557444, manalaz@clalit.org.il
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01210833
- Sponsor's protocol ID
- MMC10k112/2010CTIL
- Status last verified
- Apr 2018
- First submitted
- 29 Aug 2010
- Last updated
- 17 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using HandTutor With Traumatic Hand Injuries: Characterizing the System
- ClinicalTrials.gov ID
- NCT01210833
- Acronym / sponsor ID
- MMC10k112/2010CTIL
- Conditions
- Hand Injuries
- Keywords
- Finger Fractures, Tendon Injuries, Soft Tissue Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Oct 2010 (actual)
- Primary completion
- Feb 2012 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 29 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
HandTutor is a computerized system designed to evaluate and rehabilitate hand function. It is composed of a glove with optic sensors detecting the movements of the wrist and the fingers with a biofeedback software designed to evaluate and then to exercise the hand movements through supplying a variety of computer graphic patterns.
The HandTutor has been used and tested with a stroke population, and it seems potential to be used with hand injuried population. As a first step, it is important to investigate the characteristics of the system and how it is matching the hand injuried population.
The purpose if this study is to characterize the HandTuror system and the focused objectives are:
- To examine the test-retest reliability of the system when measuring the range of motion (ROM) of the the fingers among healthy people (control group).
- To examine the correlation between the ROM measured by the HandTutor and the ROM measured by conventional assessment tools (goniometer).
- To examine the ability of the system to distinguish between healthy people and hand injured people.
- To examine the correlation between the performance in the HandTutor (in the games part), and the performance in functional activities.
- To examine the participants feedback for using the HandTutor (degree of enjoyment).
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy participants | Active comparator | Device: HandTutor SystemHealthy participants aged from 18 to 60 with no history of hand injuries recruited by convenience sampling. |
| Hand Injured participants | Experimental | Device: HandTutor SystemParticipants with hand injuries aged from 18 to 60 recruited from the outpatients attending the occupational therapy clinic. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Hand Injuries causing a disfunction of one finger or more of the fingers 2nd-5th.
- Six weeks at least after the injury/surgery.
- Allowed to exercise their fingers with no contraindications according to the orthopedic surgeon instructions.
- With no open wounds.
Key exclusion criteria (6 listed)
- Peripheral nerves injuries.
- Digital nerves injuries.
- Sensation problems.
- CRPS-complex regional pain syndrome.
- Cognitive impairments.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HandTutor SystemComputerized system designed to evaluate and rehabilitate hand function. It is composed of a glove with special sensors detecting the movements of the wrist and the fingers, with a biofeedback software designed to evaluate and then to exercise the hand movements through supplying a variety of computer graphic patterns. | Device | Hand Injured participants, Healthy participants |
Primary outcome
range of movement (ROM)
Time frame: up to 12 months after the injury
Passive and active ROM measured by goniometer, passive and active ROM measured by HandTutor
5 secondary outcomes
performance in HandTutor
Time frame: up to 12 months after the injury
daily life functioning
Time frame: up to 12 months after the injury
motor performance skills
Time frame: up to 12 months after the injury
enjoyment
Time frame: up to 12 months after the injury
pain
Time frame: up to 12 months after the injury
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2018.
Related trials for Hand Injuries
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Effect of Rimonabant on Hand Function in Patients With Spinal Cord Injury
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Ultrasound-Guided Repeated Saline Injections to Prevent and Treat Tendon Adhesions After Hand Tendon Repair
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manal A. Najjar, M.Sc. in O.T study director
Clalit Health Service, Southern Clinic, Occupational Therapy Department, Naẕerat 'Illit, Israel, 04-6557444, manalaz@clalit.org.il
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HandTutor System in people with Hand Injuries, run by Meir Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
range of movement (ROM) (time frame: up to 12 months after the injury). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2018.